Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)

NCT ID: NCT06497101

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2028-09-01

Brief Summary

The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.

Detailed Description

Participants in the intervention arm will receive five days of TBT-S in addition to treatment as usual. TBT-S is administered to three to six adult anorexia nervosa patients with up to four supports per patient. The treatment structure consists of five consecutive days of treatment, up to 7,5 hours each day. Staff requirements for TBT-S are three clinicians, one dietician and one medical staff. Adults referred to a local psychiatric centre (DPS) for out-patient anorexia nervosa treatment, and their supports, will be eligible to participate in the study.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temperament Based Therapy with Support (TBT-S)

TBT-S in addition to treatment as usual

Group Type: EXPERIMENTAL

Temperament Based Therapy with Support (TBT-S)

Intervention Type: BEHAVIORAL

Participants included in the intervention arm will receive TBT-S (5-day treatment) in addition to treatment as usual (TAU)

Treatment as Usual (TAU)

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Temperament Based Therapy with Support (TBT-S)

Participants included in the intervention arm will receive TBT-S (5-day treatment) in addition to treatment as usual (TAU)

Intervention Type: BEHAVIORAL

Other Intervention Names

TBT-S

Eligibility Criteria

Inclusion Criteria

• Age ≥18, all genders
• A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexia nervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexia nervosa)
• Willingness to have Support(s) participate in treatment
• Medically stable

Exclusion Criteria

• Diagnosis of Intellectual Disability or Schizophrenia spectrum/other psychotic disorder
• Diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study
• Receiving in-patient treatment at time of study entry
• Presence of other psychopathology that might interfere with ability to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristin Stedal

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital, Regional Department for Eating Disorders

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Facility Contacts

Kristin Stedal, PhD

Role: primary

krsted@ous-hf.no

+4791321971

Other Identifiers

728279

Identifier Type: -

Identifier Source: org_study_id